Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia.
This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. Subjects will complete three treatment phases, each involving 5 straight days of taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
New York State Psychiatric Institute
New York, New York, United States
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
Compare effect of active drug (AVL-3288) to placebo on RBANS total score
Time frame: End of each 5-day treatment phase
RBANS index T-score subscales
Compare effect of active drug (AVL-3288) to placebo on RBANS index T-score subscales
Time frame: End of each 5-day treatment phase
Brief Psychiatric Rating Scale (BPRS) Total score
Compare effect of active drug (AVL-3288) to placebo on BPRS Total Score.
Time frame: End of each 5-day treatment phase
Calgary Depression Rating Scale (CDRS) Total score
Compare effect of active drug (AVL-3288) to placebo on CDRS Total Score.
Time frame: End of each 5-day treatment phase
Scale for the Assessment of Negative Symptoms (SANS) Total score
Compare effect of active drug (AVL-3288) to placebo on SANS Total score
Time frame: End of each 5-day treatment phase
P50 suppression measured by electroencephalographic (EEG)
Compare P50 suppression measured by EEG between active drug (AVL-3288) and placebo
Time frame: End of each 5-day treatment phase
Intensity of hippocampal BOLD fMRI signal during MRI scan
Compare intensity of Hippocampal BOLD signal between active drug (AVL-3288) and placebo
Time frame: end of each 5-day treatment phase
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